NCT04337528

Brief Summary

This study assesses the effect of manipulative techniques of thrust and muscle-energy over the sacroiliac joint on plantar foot support, weight distribution in the lower limbs and balance in amateur runners with sacroiliac dysfunction. participants will be randomly assigned to one of 3 manipulations (i.e., intervention): thrust, muscle-energy or placebo.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

February 18, 2020

Last Update Submit

November 11, 2020

Conditions

Keywords

osteopathybaropodometry

Outcome Measures

Primary Outcomes (5)

  • Change in Weight Distribution

    The baropodometry platform will be used to measure the distribution of weight (%) between legs.

    throughout study completion, an average of 1 month

  • Center of Gravity Displacement

    The baropodometry platform will measure the distance traveled (mm in x- and y-axis)

    throughout study completion, an average of 1 month

  • Center of Pressure Displacement

    The baropodometry platform will measure the distance traveled (mm in x- and y-axis)

    throughout study completion, an average of 1 month

  • Change in Plantar support

    The baropodometry platform will measure the distribution of weight (%) across the foot (i.e., forefoot and rearfoot)

    throughout study completion, an average of 1 month

  • Foot Plantar Pressure

    The baropodometry platform will measure the points of pressure across the foot with the aid of colorimetry (N/cm2)

    throughout study completion, an average of 1 month

Study Arms (3)

Thrust Group

EXPERIMENTAL

Participant will receive the thrust technique manipulation of the affected sacroiliac joint.

Other: Osteopathic manipulation type muscle-energyOther: Placebo technique

Muscle-energy group

ACTIVE COMPARATOR

Participant will receive the muscle-energy technique manipulation of the affected sacroiliac joint.

Other: Osteopathic manipulation type thrustOther: Placebo technique

Placebo Group

PLACEBO COMPARATOR

Participant will receive a placebo manipulation of the affected sacroiliac joint.

Other: Osteopathic manipulation type thrustOther: Osteopathic manipulation type muscle-energy

Interventions

The osteopathic manipulation type thrust is applied to solve the sacroiliac joint dysfunction. This technique applies a high velocity and intensity push in a specified direction to correct the dysfunction produced by a not correct position or movement of one joint.

Muscle-energy groupPlacebo Group

The muscle-energy manipulation is applied to solve the sacroiliac joint dysfunction. This technique applies a movement with an intermittent resistance in a specified direction to correct the position or movement of one joint. The therapist applies the movement in the correct direction since he feels a limitation of movement. When he feels the limitation he requests to the participant pushing in the contrary direction without movement. After five or seven seconds the participant finishes the contraction and the therapist continues the correct movement since he feels once again the limitation, and he request to the participant contraction another five or seven seconds. The therapist request to the participant only three times, when he finish the three contraction and the therapy applies the last movement to correct direction the intervention finishes.

Placebo GroupThrust Group

The therapist simulates a false technique. The therapist applies movement in the sacroiliac joint without dysfunction, he applies movement since ninety degrees of pelvic flexion, and he wait sixty seconds. Whit this placebo technique the sacroiliac joint with the dysfunction is not altered.

Muscle-energy groupThrust Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Amateur runners who perform between 10-30 km per week) and present a sacroiliac joint dysfunction.

You may not qualify if:

  • Low back pain
  • Vertebral bone pathology
  • Radicular neurological condition
  • Fracture or recent surgical intervention in the lumbosacral or pelvic region
  • Anatomical short leg with a difference greater than 0.5 cm
  • Pregnant
  • Fear of manipulation technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCAM Research Center for High Performance Sport

Guadalupe, Murcia, 30107, Spain

RECRUITING

Study Officials

  • Linda H Chung, PhD

    UCAM Research Center for High Performance Sport

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda H Chung, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and the assessor of pre-post-biomechanical measurements will be blinded to which manipulation the participant has been assigned to. The manipulation intervention will be performed by a separate physical therapist who is not involved with the biomechanical measurements.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group 1: Thrust technique Group 2: Muscle-energy technique Group 3: Placebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Contracted Professor (Contratado Doctor)

Study Record Dates

First Submitted

February 18, 2020

First Posted

April 7, 2020

Study Start

January 7, 2020

Primary Completion

March 30, 2021

Study Completion

June 30, 2021

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations